Recruiting

Fluoxetine, Buspirone, Bupropion

Sponsor:

TEMPVA Research Group, Inc.

Code:

NCT00633685

Conditions

Posttraumatic Stress Disorder, Combat-related

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fluoxetine

Placebo

Study Details

Brief summary:

Three hundred (300) male or female outpatients, over 18 years of age, will be enrolled in this study to determine whether fluoxetine can be used as a treatment for Posttraumatic Stress Disorder in soldiers recently returning from combat exposure. There will be two phases to the study. In Phase I Fluoxetine + usual psychological care will be compared with Placebo + usual psychological care over a 12-week period. Subsequently, in Phase II all subjects will be offered the opportunity to enroll in a 20-week open-label trial on Fluoxetine. If response is inadequate, adjunctive treatment with either buspirone or bupropion will be offered. The investigational drugs are Fluoxetine, Buspirone and Bupropion. All are commercially available.

Conditions

Posttraumatic Stress Disorder, Combat-related

Study ID

NCT00633685

Start date

Mar, 2010

Status verified date

Feb, 2010

Completion date

Aug, 2012

Anticipated

Primary completion date

Jun, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Veteran of the OEF/OIF war campaigns with violence exposure sufficient to qualify for a diagnosis of PTSD
2. DSM-IV diagnosis of Post-Traumatic Stress Disorder as determined by the CAPS.
3. Entry Total CAPS score of at least 65
4. No exposure to psychotropic medications except for zolpidem for at least two weeks (five weeks for fluoxetine) prior to the baseline assessments.
5. If female, a negative beta-human chorionic gonadotropin pregnancy test and willing to use oral contraceptives

Exclusion Criteria:

1. History of intolerance to fluoxetine
2. History of lack of responsivity to a 60 mg daily dose of fluoxetine
3. Current or past history of Bipolar Disorder or Schizophrenia
4. Diagnosis of Major Depressive Disorder, Obsessive-Compulsive Disorder, or Other Anxiety Disorder, unless PTSD is the principal focus of treatment and the onset of PTSD preceded that of the concurrent disorders
5. Significant history of suicidal or homicidal behavior/ideation
6. Substance dependence in the past 6 months
7. Serious general medical condition that would risk the patient being able to complete the pharmacological trial with fluoxetine
8. Concomitant use of other antidepressants, antipsychotics or mood stabilizers
9. If female, pregnancy or unwilling to use oral contraceptives
10. Participation in another research drug trial within 30-days of enrollment

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Fluoxetine

Receives Fluoxetine at 20-60 mg daily for 12 weeks in a flexible dosage schedule based upon clinical response

placebo comparator: Placebo

Interventions

Fluoxetine

Fluoxetine will be administered at 20-60 mg daily for 12 weeks in a flexible dosage schedule based upon clinical response

Placebo

Placebo will be empty gelatin capsules that are identical in size and shape to active treatment

Primary outcome measure

  • Clinician Administered PTSD Scale [ Time Frame: 12-Weeks ]

Central Contacts and Locations

Central contacts

Paul B Hicks, M.D., Ph.D.

254-743-2643paul.hicks@va.gov

Locations

Carl R. Darnall Army Medical Center

Recruiting

Ft. Hood, Texas, United States, 76544-4752

Contacts

Principal Investigator:

Michael Adams, Ph.D.

More Information

Sponsor

TEMPVA Research Group, Inc.

Last update posted

May 25, 2010

Last verified

Feb, 2010

Keywords

  • Posttraumatic Stress Disorder
  • Fluoxetine
  • Factors predicting response
  • Resilience
  • Pharmacologic augmentation strategies

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by TEMPVA Research Group, Inc. on 2010-05-25.